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Business & Regulation Standards & Regulation

Adapting to Adaptive Licensing

Lynn Baird referred to adaptive licensing as the “future of licensing” in the November issue of The Medicine Maker (“Adapting to the Future of Licensing” [tmm.txp.to/0214/adapting]) and it seems that many companies feel the same way. A recent progress report released by the European Medicines Agency (EMA) shows that 34 submissions had been received as of December 2014 for its adaptive licensing pilot project – Adaptive Pathways.

Adaptive licensing has a more staggered approval process, with the medicine first authorized in a restricted patient population under close monitoring. If all goes well, the marketing authorization can gradually be expanded to new patient populations, with data being accumulated along the way.

The majority of the requests received by the EMA related to anticancer medicines and orphan medicines, and six submissions have now been selected for what the EMA refers to as a ‘Stage II meeting’, which involves an in-depth discussion with all stakeholders. One such meeting has already taken place and the others are planned for 2015.

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About the Author

Stephanie Sutton

Making great scientific magazines isn’t just about delivering knowledge and high quality content; it’s also about packaging these in the right words to ensure that someone is truly inspired by a topic. My passion is ensuring that our authors’ expertise is presented as a seamless and enjoyable reading experience, whether in print, in digital or on social media. I’ve spent seven years writing and editing features for scientific and manufacturing publications, and in making this content engaging and accessible without sacrificing its scientific integrity. There is nothing better than a magazine with great content that feels great to read.

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